Saturday, December 13, 2025 10:42:49 AM
One would think that with the very high rate of turnover from the original trial into the extention study (guided over 90%) that we would have more than 78 of the early Alzheimer's patients (at last count) continuing and benefitting from treatment. I would be "very excited" if it were double that population.
The Therapeutic Candidates (pipeline) on the website reads like a major pharmaceutical company. This plus the mystery indication is another muse.
I would be very excited if we had one or two P3 trials up and running (PD + Fragile X). Consider this another muse as Anavex has been "rounding the corner " for more than two years of nothing here...
This CEO, unless there is a master grand plan that he and Kellmeyer are working on, has put the company and its science in a very vulnerable place. It felt like at the beginning of '25 that we would be applying to many other (actually named) countries by this time!
Now all we know is this from the horses mouth for the entire companies future:
We believe that the initiated dialogue reinforced our shared commitment to addressing the urgent unmet need in Alzheimer’s disease,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Our team is committed to continue working in partnership with regulatory bodies in order to advance science and potentially new oral treatment options for patients and their families.”
Now, we can possibly "expect" or God help us "believe" as per Misslings latest words that "initiated dialog and reinforced shared commitment" can turn into an upcoming PR of CHMP re-examination acceptance and a positive opinion come April. If this path happens, then MIssling can actually use the word decision (instead of feedback) while anticipating the final EMA word. Inbetween that, I guess they can apply for approval with all current data elsewhere (that would surely be a sign of confidence), shop around at JP Morgan or start a new P#3 trial.
Happy Holidays and good health to all here and see you in '26...
Recent AVXL News
- Anavex withdraws EU approval filing for Alzheimer’s therapy • IH Market News • 03/30/2026 12:39:26 PM
- Anavex Life Sciences Provides Comprehensive Regulatory Update • GlobeNewswire Inc. • 03/30/2026 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/25/2026 08:06:00 PM
- Anavex withdraws EU marketing application for Alzheimer’s therapy blarcamesine • IH Market News • 03/25/2026 02:06:58 PM
- Anavex Life Sciences Provides Update on Regulatory Review in the EU for Blarcamesine to Treat Early Alzheimer’s Disease • GlobeNewswire Inc. • 03/25/2026 11:30:00 AM
- Anavex Life Sciences Presents New Data from its AD-004 Phase IIb/III Trial at AD/PD 2026 Conference Demonstrating Consistent Correlation Between the Treatment Effect of Oral Blarcamesine and Preservation of Brain Volume in Early Alzheimer’s Disease • GlobeNewswire Inc. • 03/23/2026 11:30:00 AM
- New Scientific Findings Highlight Hypothesis of Autophagy Failure as a Precursor of Amyloid Beta and Tau Pathology in Alzheimer’s Disease • GlobeNewswire Inc. • 03/20/2026 11:30:00 AM
- Anavex Life Sciences Presents Significant Treatment Effects of Blarcamesine in New Advanced Alpha-Synuclein Model of Parkinson’s Disease at AD/PD 2026 Conference • GlobeNewswire Inc. • 03/17/2026 11:30:00 AM
- Anavex Life Sciences to Present at the Citizens Life Sciences Conference • GlobeNewswire Inc. • 03/03/2026 12:30:00 PM
- Anavex Life Sciences to Present at the 46th TD Cowen Annual Health Care Conference • GlobeNewswire Inc. • 02/25/2026 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/25/2026 11:07:01 AM
- Anavex Life Sciences Appoints Seasoned Healthcare Leader to Board of Directors • GlobeNewswire Inc. • 02/23/2026 12:30:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/09/2026 09:40:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/09/2026 12:31:17 PM
- Anavex Life Sciences Reports Fiscal 2026 First Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 02/09/2026 12:30:00 PM
- Anavex Life Sciences to Announce Fiscal 2026 First Quarter Financial Results on Monday, February 9, 2026 • GlobeNewswire Inc. • 02/03/2026 12:30:00 PM
- Anavex Joins ACCESS-AD, a Major Initiative Funded by the European Commission, Through the Clinical Evaluation of Blarcamesine as Part of a Precision Medicine Approach in Alzheimer’s Disease • GlobeNewswire Inc. • 01/13/2026 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/09/2026 10:26:26 PM
- Edelson Lechtzin LLP Announces an Investigation of Anavex Life Sciences Corp. (NASDAQ: AVXL) and Encourages Investors with Substantial Losses Contact the Firm • PR Newswire (US) • 01/09/2026 01:13:00 AM
- Anavex Life Sciences Appoints Senior Vice President Global Head of Neurology • GlobeNewswire Inc. • 01/08/2026 12:30:00 PM
- Anavex Life Sciences Receives FDA Feedback on Alzheimer’s Disease Program • GlobeNewswire Inc. • 01/06/2026 12:30:00 PM
- Anavex Life Sciences Submitted Request for EMA to Re-Examine Its Opinion • GlobeNewswire Inc. • 12/18/2025 12:30:00 PM
- Anavex Life Sciences Provides Update on Regulatory Review in the EU for Blarcamesine to Treat Early Alzheimer’s Disease • GlobeNewswire Inc. • 12/12/2025 09:05:00 PM
- Anavex Life Sciences to Present Oral Blarcamesine Data at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) Conference • GlobeNewswire Inc. • 11/26/2025 12:30:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 11/25/2025 09:31:44 PM
Eco Science Solutions Integrates IDScan.net's DIVE Into Herbo Pay to Power Identity Verification, Compliance, and Fraud Prevention • ESSI • Mar 27, 2026 12:01 PM
The Crypto Company Acquires FRAME Blockchain's Technology, An "Interstate Highway" Liquidity Layer for Crypto Commerce • CRCW • Mar 26, 2026 12:28 PM
Resilient Energy Inc. Enters LOI Negtiations for Second Acquisition; First Acquisition Nears Closing • RENI • Mar 26, 2026 10:30 AM
Alliance Creative Group (ACGX) Releases 2025 Annual Financial and Disclosure Report • ACGX • Mar 26, 2026 8:30 AM
Isiah Enterprises Activates Scalable Materials Platform Targeting $900B+ Global Market Opportunity; Initiates Strategic Partner Alignment Phase • OWPC • Mar 25, 2026 9:07 AM
ECGI Signs Definitive $25 Million Agreement to Acquire RezyFi • ECGI • Mar 24, 2026 8:30 AM
